As surely as night follows day, the lawsuits began lining up against. Medtronic (Minneapolis) shortly after the reports of the company's recall of its Sprint Fidelis defibrillation leads in mid-October.
In their filings, individuals implanted with devices using the Fidelis lead wires are claiming that they were injured as the result of cracks that developed in the wires that connect the device to the heart. As a result of this defect, patients either received jolting shocks when they didn't need one, or the devices failed to provide the shocks that were needed.
In reporting that it would stop selling the device leads, Medtronic said it had implanted about 268,000 of the Fidelis leads, and that it had identified five patient deaths which it acknowledged may have been related to the lead fractures.
The Fidelis leads are used for implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), not the company's pacemakers.
The FDA termed Medtronic's action a product recall. However, both the company and the agency have recommended against removal of the leads, saying that the risk of replacing the device exceeds the risk of a lead fracture. Instead, they are recommending closer monitoring of the devices.
Concerns quickly spread to another company in the sector, St. Jude Medical (St. Paul, Minnesota), which quickly attempted to reassure patients and investors that there were no similar problems with its leads.
In a conference call hosted by Bear Stearns, Eric Fain, president of St. Jude's cardiac rhythm management division, rejected rumors that its Riata leads also were in line for recall. One of the concerns was that at size 6.6 Fr, the Fidelis leads were the smallest on the market, and St. Jude's Riata leads, size 7 Fr, are now the smallest.
The FDA approved the Fidelis defibrillation leads in September 2004. The small size of the Fidelis leads was intended to help improve passage into a patient's venous system for an easier implant, and minimize venous obstruction.
Citing data from three large registries on 121,000 implants, Fain reported 13 fractures, an overall rate of 0.011%, involving the Riata leads, which he noted is 20 times less than reported for Medtronic's Fidelis. Fain said that St. Jude considers the reliability of its Riata leads to be "quite good" and having the "highest reliability yet."
But that call was followed by the need to do more PR blocking and tackling with the release in early November of the report in the journal Pacing and Clinical Electrophysiology that St. Jude's leads had been responsible for perforation of the hearts of four patients, one of the incidents reported as a lead having moved from inside the heart to just under the patient's skin.
The journal said that four women had their leads removed because of the perforation — one in Nebraska, one in New York, two in the Czech Republic. An editorial in the journal said the perforations were serious because often not discovered until the leads have punctured the heart wall.
The editorial also suggested large that there may be significant under-reporting of the incidents if cardiologists considered them as isolated occurrences.
St. Jude immediately issued a response to the article and editorial, saying that the risk of perforation by the device leads is "well known" and that the rate of perforations by its Riata leads has been below that of leads made by other companies.
Reports of the journal article caused an immediate 5% drop in St. Jude's share price, but analysts were generally not too worried. Some said that the focus on St. Jude was a halo effect resulting from Medtronic's recall, and that the rate of problems with the Rita leads appeared much less than that with the Fidelis leads.
During the Bear Stearms conference call, Kenneth Ellenbogen, MD, an electrophysiologist, noted that ICD fractures have generated considerable bad publicity in recent years.
Ellenbogen, vice chairman of cardiology at Virginia Commonwealth University (VCU; Richmond) and director of clinical cardiac electrophysiology and pacing at VCU, told listeners that he began decreasing the use of Medtronic leads about six months ago after noticing that the Fidelis was not performing as well as others on the market.
Ellenbogen rightly predicted that the recall would hurt other companies with ICD leads on the market because more physicians will decide to hold off on implanting patients with ICDs. "The biggest bad thing that's going to come out of this is [leaving] a bad taste in people's mouths about ICDs," he said.
He said that his office had received a number of calls from patients and that he plans to follow Medtronic's recommendations by reprogramming affected patients' devices to more effectively monitor for potential problems and provide an audible alert in the event of lead fractures. "I don't want a bunch of people coming in after they've gotten 25 [inappropriate] shocks," he said.